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Market Access

With the exception of custom-made devices and medical devices manufactured in-house, medical devices pursuant to § 11, paragraph 1 MPG (Act on Medical Devices), as well as medical devices intended for clinical investigation, or in vitro diagnostic medical devices intended for performance evaluation, medical devices may only be placed on the market or put into service if they bear the CE marking.

Medical devices may only bear the CE marking if the essential requirements, which are applicable to them taking into consideration their intended purpose, are fulfilled and the conformity assessment procedure prescribed for the medical device in has been conducted.

The essential requirements for active implantable medical devices, are the requirements contained in Annex 1 to Council Directive 90/385/EEC of 20th June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (O.J. EC No. L 189, p. 17), last amended by Directive 93/68/EEC (O.J. EC No. L 220, p. 1), for in vitro diagnostic medical devices the requirements contained in Annex 1 to Directive 98/79/EC, and for other medical devices, the requirements contained in Annex 1 to Council Directive 93/42/EEC of 14th June 1993 on medical devices (O.J. EC No. L 169, p. 1), last amended by Directive 2000/70/EC (O.J. EC No. L 313, p. 22), in the valid version in each case.

European Directives concerning Medical Devices

The CE marking shall be used for active implantable medical devices according to Annex 9 to Directive 90/385/EEC, for in vitro diagnostic medical devices according to Annex X to Directive 98/79/EC, and for the other medical devices according to Annex XII to Directive 93/42/EEC. Marks and inscriptions which are likely to mislead third parties with regard to the meaning or graphic design of the CE marking may not be used. All other marks may be affixed to the medical device, the packaging or the instructions for use provided that the visibility and legibility of the CE marking is not reduced as a result.

The CE marking must appear in a clearly visible, legible and indelible form on the medical device and, where applicable, on the sales packaging and instructions for use. It is not necessary for the CE marking to appear on the medical device if the latter is too small, its nature does not allow for it or if it is not appropriate. The CE marking must be accompanied by the identification number of the relevant Notified Body which was involved in the conformity assessment procedure pursuant to Annexes 2, 4 and 5 to Directive 90/385/EEC, Annexes II, IV, V and VI to Directive 93/42/EEC, as well as Annexes III, IV, VI and VII to Directive 98/79/EC, which resulted in the right to affix the CE marking. In the case of medical devices which have to bear a CE marking and which are placed on the market in a sterile condition, the CE marking must appear both on the sterile packaging and on the sales packaging where appropriate. Where a conformity assessment procedure which is not to be conducted by a Notified Body is stipulated for a medical device, the CE marking may not be accompanied by the identification number of a Notified Body.

Notified Bodies

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Placing on the market is any act of supplying medical devices to others either free of charge or in exchange for payment. First placing on the market is the first making available a new or fully refurbished medical device to others in the European Economic Area.

The person responsible for the first placing on the market of the device is the manufacturer or his or her authorised representative. If the manufacturer does not have his/her registered place of business in the European Economic Area and if an authorised representative has not been designated, or if medical devices are not being imported into the European Economic Area under the responsibility of the authorised representative, the importer shall be the person responsible. The name or the firm and the address of the person responsible must appear on the label or in the instructions for the use of the medical devices.

The manufacturer is the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a medical device with a view to its placing on the market for the first time under his own name, regardless of whether those operations are carried out by that person himself or on his behalf by a third party. The obligations incumbent on manufacturers under the MPG also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more prefabricated medical devices or is responsible for assigning to them their intended purpose as medical devices with a view to their placement on the market for the first time under his name.

The authorised representative is the natural or legal person established in the European Economic Area, who has been explicitly designated by the manufacturer, with a view to his obligations under the MPG, to act on his behalf and to be at the disposal of the authorities and competent bodies.

The first placing on the market of a medical device by a responsible person who has his registered place of business in Germany must be notified to the local authority of the concerned federal state. A list of the authorities as well as the information for notification is available on the DIMDI website. The form concerning notification of the first placing on the market of in vitro diagnostic medical devices can be downloaded from the following DIMDI website.